Case studies in Bayesian methods for biopharmaceutical CMC. (2022)

• Record Type: Book
• Further Information: Note: Edited by Paul Faya, Tony Pourmohamad.
• Editors: Faya, Paul; Pourmohamad, Tony
• Contents: 1. Introduction Paul Faya and Tony Pourmohamad 2. An Overview of Bayesian Computation David J. Kahle, John W. Seaman Jr., and James D. Stamey 3. Basic Bayesian Model Checking; ; John W. Seaman Jr., David J. Kahle, and James D. Stamey; ; 4. Quantitative Decision - Making, a CMC application to analytical method equivalence Misbah Ahmed and Mike Denham 5. Bayesian Dissolution Testing Tony Pourmohamad and Robert Richardson 6. A Non-Normal Bayesian Model for the Estimation and Comparison of Immunogenicity Screening Assay Cut-Points David LeBlond and Robert Singer, Lu Xu, and Rong Zeng; ; 7. Application of Bayesian Hierarchical Models to Experimental Design Adam P. Rauk and Paul Faya 8. Bayesian Prediction for Staged Testing Procedures Katherine E.D. Giacoletti and Tara Scherder 9. A Bayesian Approach to Multivariate Conditional Regression Surrogate Modeling with Application to Real Time Release Testing Stan Altan, Dwaine Banton, Hans Coppenolle, Martin Kovarik and Martin Otava, and Christian Schmid ; ; 10. Bayesian Approach for Demonstrating Analytical Similarity Harry Yang and Steven Novick 11. Bayesian Evaluation and Monitoring of Process Comparability; ; Ke Wang and Aili Cheng; ; 12. Bayesian Alternatives to Traditional Methods for Estimating Product Shelf Life and Internal Release Limits Perceval Sondag, Ji Young Kim, Laurent Natalis, and Tara Scherder 13. Application of Bayesian Methods for Specification Setting Chris Thompson and Guillermo Miro-Quesada; ; 14. Calculating Statistical Tolerance Intervals Using SAS Richard Lewis and Buffy Hudson-Curtis 15. A Bayesian Application in Process Monitoring – Establishing Limits for Dosage Units in Early Phase Process Control Yanbing Zheng, James Reynolds, Man Tang, Mark Johnson and Hesham Fahmy
• Edition: 1st
• Publisher Details: Boca Raton : Chapman & Hall/CRC
• Publication Date: 2022
• Extent: 1 online resource
• Subjects: 615.701519542; Biopharmaceutics -- Mathematical models; Pharmaceutical biotechnology; Bayesian field theory; Bayesian statistical decision theory; Biopharmaceutics -- Case studies
• Languages: English
• ISBNs: 9781000824865; 9781000824773
• Related ISBNs: 9781032185484
• Notes: Note: Description based on CIP data; resource not viewed.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.